Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04805307
Status:
RECRUITING
Last Update Posted:
2022-12-28
First Post:
2021-03-16
Brief Title:
Safety Tolerability Pharmacokinetics and Preliminary Efficacy Phase 1 Study of CMG901
Sponsor:
Keymed Biosciences CoLtd
Organization:
Keymed Biosciences CoLtd
Study Overview
Official Title:
An Open-Label Phase 1 Dose Escalation and Dose Expansion Study to Evaluate the Safety Tolerability Pharmacokinetics and Antitumor Activities of CMG901 in Subjects With Advanced Unresectable or Metastatic Solid Tumor
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label dose escalation and dose expansion Phase 1 study to evaluate the safety tolerability PK and preliminary anti-tumor activity of CMG901
The dose escalation part Part A will determine the MTD of CMG901 in subjects with relapsed andor refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit or the subject is not a candidate for such available therapy based on a modified 33 dose escalation design an accelerated dose titration design followed by traditional 33 dose escalation design
The dose expansion part Part B will evaluate the preliminary anti-tumor activity and safety of CMG901 in subjects with Claudin 182 positive gastric cancer GC gastroesophageal junction GEJ cancer and pancreatic cancer who have relapsed andor are refractory to approved therapies
The dose escalation part Part A will determine the MTD of CMG901 in subjects with relapsed andor refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit or the subject is not a candidate for such available therapy based on a modified 33 dose escalation design an accelerated dose titration design followed by traditional 33 dose escalation design
The dose expansion part Part B will evaluate the preliminary anti-tumor activity and safety of CMG901 in subjects with Claudin 182 positive gastric cancer GC gastroesophageal junction GEJ cancer and pancreatic cancer who have relapsed andor are refractory to approved therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None